Various sterile packages are used to hold medical components (i.e., devices and equipment) or instruments for surgical procedures. One type of packaging is a molded or thermo-formed sterilized substantially rigid plastic container capable of holding various components. Another type is a flexible pouch into which equipment and supplies can be inserted. The necessary supplies and equipment for a particular surgery are packaged together, sterilized, and delivered to the operating room ready for use.
The current method of packaging oxygenators (i.e., equipment to substitute for lung function during heart by-pass surgery) typically is "bagging" the device in a flexible permeable bag. The device in the bag may be supported by formed plastic within the bag. Supports outside the bag may also used. Such include formed or die-cut foam, die-cut corrugated paperboard, or formed plastic. The flexible permeable bag seals in the oxygenator and acts as a sterile barrier. However, maintaining a sterile barrier with a flexible bag is difficult for a device such as an oxygenator, which may weigh as much as about 6 lb. (2.7 kg), and which contains multiple sharp protrusions (e.g., ports, stopcock manifolds, and mating edges of rigid plastics). Moreover, a flexible bag functions poorly in distributing forces of the oxygenator within the bag, creating pressure points vulnerable to vibrational friction and shock. In addition, the bag can be damaged during handling (before surgery) when the bag and its contents are removed from its shipping container.
Oxygenators are part of perfusion systems used in heart surgery. Similar packaging issues have arisen for perfusion equipment other than oxygenators. Perfusion systems typically contain one or more of an oxygenator, tubing sets, filters, blood reservoirs, sensors, connectors, blood cooling coils and other items comprising an extracorporeal blood circuit that may be used in heart by-pass procedures.
A technician assembles and packages the components of a perfusion system to the specifications of a particular hospital, typically as defined by the surgical team. Thus there are a variety of types of such packages on the market and the components of these packages may very greatly. For example, in addition to the variability in the number and type of components present in the package, the components may be connected in a sequence and with varying lengths of tubing as specified by the surgical team. It is frequently desirable to provide the packages "pre-connected", so that very little, if any, set up of the packaged components is required.
One currently available perfusion package is a rigid thermoformed container with a rigid inner tray securely taped within the container. The inner tray holds the necessary components and devices of the perfusion package by various shaped holders, adhesive tapes, and fasteners. The container is sealed with a breathable covering, such as a polyethylene membrane (such as that commercially available under the trade designation TYVEK.TM. from E. I. DuPont deNemours and Co.). A breathable covering permits sterilization of the package with ethylene gas.
Another commercial product is a two-tiered system having a rigid thermoformed plate separating the tubing sets on the bottom tier of a rigid container from the oxygenator and pump lines on the top tier. The contents of the package are secured by using shrink-wrap film. The entire tray is covered with sterile surgical paper and sealed in a breathable bag. The system is sterilized and then shipped to the customer.
Yet another packaging system is a semi-rigid corrugated plastic tray that has metal framing to provide added support to the tray. Devices and components are strapped within holders or formed parts that are adhered to the floor of the tray and secured with mechanical fasteners. Once the tray has been packed, it is covered with a corrugated plastic lid. The entire system is placed into a breathable sterile barrier bag for sterilization before use.
Current packaging systems share some disadvantages. Current systems typically are packed to each customer's specifications so each package may have different components in it. There is no defined position in the package for a component. Typically the technician who is packing perfusion equipment loads in the medical components and restrains them from movement by means of various fasteners. Because of this, the systems are not only time-consuming to pack but operator inconsistencies develop because of variable placement of the components. These disadvantages also lead to more costly assembly time.
Disposal of the package, once the components in the package have served their use in surgery, can also be problematic. Typically, the components and the package are placed in bags or pouches for removal and disposal. This also is an additional expense and can be time consuming.
Thus, a need in the art exists for a packaging system for medical components which provides ease of assembly and use, adequate support and cushioning for the components, the ability to vary the types of components without changing the package, and a way to dispose of the package inexpensively and conveniently.